The mammalian spine consists of bones called vertebrae, which are separated by soft cushions referred to as intervertebral discs. The thick portion of bone at the front of each vertebra is referred to as the vertebral body. When a vertebral body collapses, a vertebral compression fracture (VCF) of the bone results. Most vertebral compression fractures are caused by osteoporosis, a disease that causes bones to become brittle and to break easily. Because osteoporosis usually progresses without obvious symptoms, an individual may not be aware that he or she has the disease until a fracture actually occurs. The pain and loss of movement that often accompanies fractures of the spine are perhaps the most feared and debilitating side effects of osteoporosis. When a spinal compression fracture occurs as a result of osteoporosis, the vertebrae in the thoracic (chest) and lower spine that are usually affected. For many people with osteoporosis a spinal fracture results in severely limited activity, constant pain and serious reduction in quality of life.
While there is no known cure for osteoporosis, there are treatments and prevention measures available to reduce the risk of pathologic fractures. The three mainstays of osteoporosis treatment are (1) weight-bearing exercise; (2) nutrition supplementation such as supplemental calcium; and (3) medications such as bisphosphonates, calcitonin, raloxifene and estrogen. Despite such treatments approximately 700,000 vertebral compression fractures occur each year, usually in women over the age of 60, and it has been estimated that at least 25 percent of women and a somewhat smaller percentage of men over the age of 50 will suffer one or more spinal fractures.
Other medical conditions known to contribute to vertebral compression fractures include cancer, benign tumors or lesions and various types of trauma. Cancerous lesions include multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma, while benign lesions include hemangioma and giant cell tumors. Additionally, younger individuals may also suffer such vertebral compression fractures, particularly individuals whose bones have become fragile due to the long-term use of steroids or other drugs to treat a variety of diseases such as lupus, asthma and rheumatoid arthritis.
Various treatments are currently available for spinal compression fractures and such fractures may also be treated symptomatically with pain medicines. While various types of back bracing devices can also be used, such devices may actually cause weakening of the bone and predispose patients to further fractures in the future. If a compression fracture is caused by trauma, a rigid bracing that protects the bone as it heals may be required for six to ten weeks.
Many cases of vertebral compression fractures require surgery. When the compression fracture is caused by a tumor, a biopsy procedure may be performed followed by treatment of the tumor. A surgical procedure may also be required to remove any bone within the spinal canal, followed by the fusing together of the vertebra in order to stabilize the spine. Surgery is almost always required whenever there is a loss of function caused by the impingement of bone on the spinal cord or spinal nerves.
Recently, minimally invasive techniques, such as percutaneous vertebroplasty, have been used to treat compression fractures. Vertebroplasty is an image-guided, minimally invasive, non-surgical procedure used to strengthen a fractured spinal vertebra. Often performed on an outpatient basis, such procedures are normally carried out with the patient immobilized lying face down on his or her stomach while under local anesthesia and light sedation and intravenous antibiotics may also be administered to prevent infection. Then, through a small incision and under the guidance of a special x-ray imaging technique a cannulated bone needle designed for intraosseous access is guided through the skin and passed through the spinal muscles until the needle tip is precisely positioned within the fractured vertebra. At this point the interventional radiologist may perform an examination called intraosseous venography to insure that the bone needle has resides in the desired area within the fractured bone. Finally, biocompatible liquid orthopedic cement is injected through the bone needle to fill the vertebral cavity and as the needle is withdrawn, the cement hardens thereby stabilizing the vertebra and thus preventing further vertebral body collapse.
Although successful vertebroplasty has been shown to alleviate the pain caused by a compression fracture, these techniques are often deficient providing adequate stability and physiologic reconstruction of the spinal column and often prevents patients from return to a previous level of physical activity.
In vertebroplasty the most commonly used bone cements are curable compositions of poly(methyl methacrylate) containing radiopacifiers such as barium powder that render the cement visible by the same imaging technique used to guide the bone needle. It is evident that as the technology matures and become more sophisticated, there is a need for better visualization techniques to perform such complicated and delicate procedures since X-ray (fluoroscopic) guidance is the only available modality for visualization during the performance of vertebroplasty to date. Although a variety of direct visualization techniques including optical visualization (endoscopes), ultrasonography, and laser beams are well known in the art, to date these techniques have been used only in body cavities other than bony tissue.
Another minimally invasive treatment for spinal compression fractures is the balloon-assisted vertebroplasty technique known as balloon kyphoplasty. In a kyphoplasty procedure, as in a percutaneous vertebroplasty procedure, a cement-like material is injected directly into the fractured bone, however kyphoplasty includes an additional step the goal of which is to restore height to the bone thus reducing deformity of the spine. In a balloon kyphoplasty procedure an inflatable orthopedic balloon is inserted between the pieces of a collapsed vertebra and the balloon is carefully inflated to gently raise the collapsed vertebra and return it to a more normal position while the inner soft bone is compacted to create a cavity inside the vertebral body. The balloon is then deflated and removed and pasty orthopedic cement is injected through a bone needle to fill the vertebral cavity wherein the cement hardens to stabilize the raised vertebra and prevent further vertebral body collapse. However, as in the vertebroplasty procedures, balloon kyphoplasty techniques are often insufficient in providing adequate stability and physiologic reconstruction of the spinal column and often prevents patients from return to a previous level of physical activity.
Whereas the percutaneous vertebroplasty procedures discussed above are well described and widely accepted, osteoplasty of bones outside the spine is less known but is being actively studied. For example, a clinical study published by Hierholzer et al. in Journal of Vascular and Interventional Radiology, vol. 14, pp. 773-778 (2003) describes patients with painful metastases to the pelvis, ilium, or femur who were successfully treated by injection of acrylic cement into the osteolytic defect under fluoroscopic or computed tomographic (CT) guidance. Therefore, it is expected that percutaneous osteoplasty of bones outside the spine will become widely accepted.
Devices for delivering injectable biomaterials such as bone cement formulations into body cavities are known in the art. U.S. Pat. No. 7,008,433 to Voellmicke et al. describes a high-pressure bone cement injection device for use in vertebroplasty that allows for specific control of the injection of small discrete quantities of the cement. Published U.S. Pat. Application No. 2006/0074433 to McGill et al. describes an apparatus for delivering bone cement into a vertebra that includes a cannula and a pressurized delivery device in communication with the cannula. This pressurized delivery device provides an actuating force that acts either directly or through a medium to cause a flowable compound to be delivered from the delivery device to the cannula and into the vertebra. While the above referenced devices address problems relating to the viscosity of flowable compositions such as bone cements, they do not address issues relating to the precise control of placement and distribution of such compositions at a targeted injection site.
U.S. Pat. Nos. 6,019,776 and 6,033,411 to Preissman, et al. disclose methods for a controlled approach to the interior of a vertebral body involving insertion of a threaded or sharp-pointed stylet and cannula percutaneously through the soft tissue of a patient until hard tissue is abutted; further insertion of the stylet to a predetermined site within the hard tissue; ratcheting a pawl mechanism or rotating a camming mechanism to advance the cannula along the stylet to the predetermined site; withdrawing the stylet from the cannula and attaching a source of implantable material for injection of the material into the site through the cannula. U.S. Pat. No. 6,676,663 to Higueras et al. describes an applicator device utilizing a standard syringe body for controllably injecting a quantity of cement into bones, particularly, in percutaneous vertebroplasty. However, the devices described in these patents deliver the injected material only through the tip of cannula and therefore offer no control of the direction or distribution of the injected material within the organism. Furthermore, these patents do not teach methods for delivery of restorative material by percutaneous vertebroplasty by which multiple doses of material can be injected.
A report by Heini et al. in SPINE, vol. 27, No. 1, pp. 105-109 (2002) describes the evaluation of an injection cannula for the delivery of bone cement in vertebroplasty procedures using human cadaver bones, wherein the injection cannula has a single opening in the cannula wall through which the bone cement is dispensed. These researchers indicate that use of a side-opening cannula may reduce the likelihood of cement leakage into adjacent veins and subsequent embolization. However, such a cannula with a single opening in the cannula wall as described does not provide sufficient control of cement placement nor degree of directional control required to prevent extravasation in these delicate procedures.
U.S. Pat. No. 4,959,058 to Michelson describes a cannula for use with an arthroscope wherein the cannula has multiple openings in the form of multiple narrow slots radially disposed about the tip. These openings are designed to allow a low viscosity fluid such as water to be injected in a shower-like fashion as a viewing aid during the arthroscopic procedure. Such a cannula is not suitable for the injection of viscous flowable materials such as bone cement and, since the narrow openings are confined near the tip of the cannula, such a design offers no control over the placement of the fluid.
Bone screws for spinal compression fractures are well know in the art. Furthermore, U.S. Pat. No. 7,255,713 to Malek describes cannulated bone screws for delivering a treatment agent to a bone or a prosthetic vertebral body. U.S. Pat. No. 6,214,012 to Kartman et al. also describes a cannulated bone screw, which is configured for delivery of an injectable material into a bone. U.S. Pat. No. 4,653,489 to Tronzo et al. describes a fenestrated cannulated hip screw adapted for introduction of bone cement into a bone region for increase of overall fixation of hip fractures.
Various mechanical devices for the fixation and stabilization of various orthopedic fractures are know in the art. For example, US Patent Application 2003/0171812 to Grunberg et al. describes a modular support implant device consisting of a plurality of rigid plates for reconstructing and supporting a diseased or fractured bone or within a space previously occupied by a diseased intervertebral dis. The individual plates are sized to be inserted into the bone or the space through a cannula and are arranged in situ relative the adjacent plates to construct a scaffold that to function as a supporting prosthesis. US Patent Application 2003/0074075 to James et al. describes expandable implants for orthopedic uses wherein the implants are inserted into an annular defect by forceps or forcep-like implantation devices.
Therefore, in view of the prior art, there exists a need for devices and methods that permit effective delivery of a mechanical implant such as a scaffold into a bone cavity with concurrent or sequential delivery of a flowable material such as bone cement and wherein the mechanical implant is secured by an anchoring means.
There also exists a need for devices and methods for the securing the bone screws used in orthopedic procedures such as fracture fixation.
There exists a need for a reliable integrated system for fracture fixation and other such procedures that integrates the delivery of mechanical implants and introduction of bone cement wherein the system also functions to secure bone screws used in the procedure.
There exist yet other needs to provide minimally invasive techniques for the reparation and restoration of bony structures and to provide minimally invasive techniques for the augmentation of procedures requiring screw fixation.
The devices and methods of the present invention address these and other needs that will become apparent to those skilled in the art based on the following specification and the accompanying drawings.